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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023345
Receipt No. R000026902
Scientific Title Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Date of disclosure of the study information 2016/08/01
Last modified on 2018/01/26

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Basic information
Public title Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Acronym Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Scientific Title Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Scientific Title:Acronym Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Region
Japan

Condition
Condition Advanced Cancer
Classification by specialty
Hematology and clinical oncology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the effectiveness of fan to face to reduce the sensation of breathlessness in patients with advanced cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Primary outcome is change in the severity of breathlessness score using a Numerical Rating Score(NRS). NRS assessment are completed before and after the intervention/ control.
Key secondary outcomes Secondary outcome is proportion of patient experiencing benefit in breathlessness as an absolute fall of 1 point or more on the NRS scale.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Fan directed to face, the airflow to the region innervated by 2nd and 3rd trigeminal nerve branches, for 5 minutes
Interventions/Control_2 Fan directed to legs for 5 minutes
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Any patient able and willing to cooperate with the study
2. Patients with metastatic or locally advanced cancer
3. No further or current anticancer treatment
4. ECOG Performance Status = 3 or 4
5. Patients with lucidity and capability of communication in Japanese and without cognitive impairments
6. NRS levels for Dyspnea >= 3
7. SpO2 >= 90
Key exclusion criteria 1. Patients with diseases or treatment affecting the trigeminal nerve supply
2. Hb <= 6
3. Judged to be inappropriate for participation to the study by the attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Kako
Organization National Cancer Center Hospital East
Division name Division of Nursing
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577
TEL 04-7133-1111
Email jkakoh@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kako
Organization National Cancer Center Hospital East
Division name Division of Nursing
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577
TEL 04-7133-1111
Homepage URL
Email jkakoh@east.ncc.go.jp

Sponsor
Institute Division of Nursing, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization The Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 28 Day
Last follow-up date
2017 Year 08 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 26 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026902

Research Plan
Registered date File name
2018/04/24 3_20180424154017.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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